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A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients

Inclusion Criteria:

- Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions
should not be amenable to surgery or radiation of curative intent.

- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)
performance status scale.

- One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative
1st-line treatment.

- One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line

- Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants
must have recovered from the toxic effects of the treatment prior to study enrollment
(except for alopecia). Prior radiotherapy must be completed 30 days before study
entry. Lesions that have been radiated cannot be included as sites of measurable
disease unless clear tumor progression has been documented in these lesions since
the end of radiation therapy.

- At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria
in Solid Tumors (RECIST) criteria. Positron emission tomography [PET] scans and
ultrasounds may not be used.

- Antitumoral hormonal treatment must be discontinued prior to enrollment.

- Estimated life expectancy of at least 3 months.

- Participant compliance and geographic proximity that allow adequate follow-up.

- Adequate organ function

- Female participants of childbearing potential must test negative for pregnancy within
7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a
reliable method of birth control during and for 6 months following the last dose of
study drug.

- Participants must sign an informed consent document.

- Female participants must be at least 18 years of age.

Exclusion Criteria:

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.

- Have previously completed or withdrawn from this study or any other study
investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine

- Have received more than one line of chemotherapy in Metastatic Breast Cancer.
Participants having received more than one combination of anthracycline plus taxane.

- Are pregnant or breast-feeding.

- Have serious concomitant systemic disorders (e.g., active infection) that, in the
opinion of the investigator, would compromise the safety of the participant or
compromise the participant's ability to complete the study.

- Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or
nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively
treated at least 5 years previously with no subsequent evidence of recurrence.

- Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a
5-day period (8-day period for long-acting agents such as piroxicam), unless the
Creatinine Clearance is greater than or equal to 80 ml/min.

- Have central nervous system (CNS) metastases.

- Have clinically relevant (by physical exam) third-space fluid collections (for
example, ascites or pleural effusions) that cannot be controlled by drainage or other
procedures prior to study entry.

- Are unable or unwilling to take folic acid, vitamin B12 supplementation, or

- Concurrent administration of any other antitumor therapy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate

Outcome Description:

Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.

Outcome Time Frame:

Baseline up to 30 days of follow-up after 21 cycles of treatment

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2006

Completion Date:

August 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms